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A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy

NCT03338062

Description:

The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.

Related Conditions:
  • Cholangiocarcinoma
  • Hepatocellular Carcinoma
Recruiting Status:

Completed

Phase:

N/A

Trial Eligibility

Document

Title

  • Brief Title: A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy
  • Official Title: A Pilot Study to Assess Theragnostically Planned Liver Radiation With Functional DVH Analysis to Optimize Individualized Radiation Therapy

Clinical Trial IDs

  • ORG STUDY ID: IUSCC-0604
  • NCT ID: NCT03338062

Conditions

  • Liver Cancer
  • Hepatocellular Carcinoma
  • Cholangiocarcinoma

Purpose

The purpose of this study is to compare radiation treatment plans that are designed for patients with liver cancer. One treatment plan will be created using routine procedures and scans normally performed for radiation treatment planning. The other treatment plan will be created using routine procedures with the addition of two imaging scans; a HIDA (Hepatobiliary Iminodiacetic Acid) scan and an MRI (Magnetic Resonance Imaging) scan. This study will evaluate if adding these imaging scans to treatment planning can reduce the amount of radiation to healthy liver tissue during treatment.

Trial Arms

NameTypeDescriptionInterventions
HIDA and MRI ScanExperimentalTwo imaging scans will be added to the standard radiation planning, treatment and follow up process; a Hepatobiliary Iminodiacetic Acid (HIDA) scan and an MRI scan with Eovist contrast

    Eligibility Criteria

            Inclusion Criteria:
    
              -  Primary liver malignancy including hepatocellular carcinoma (HCC) or
                 cholangiocarcinoma
    
              -  Subjects must have a Child-Turcotte-Pugh (CTP) score ≤ 7 to be eligible
    
            Exclusion Criteria:
    
              -  Subjects who are pregnant or planning to become pregnant during the study.
    
              -  No more than 3 lesions can be treated. Total diameter of all lesions must be less than
                 or equal to 6 cm
    
              -  Prior radiation treatment to the upper abdomen
    
              -  Active infection, active upper GI ulceration or hemorrhage, symptomatic congestive
                 heart failure, unstable angina pectoris, cardiac arrhythmia
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Functional reserve of Liver
    Time Frame:Day -1 of Radiation Treatment
    Safety Issue:
    Description:The functional reserve will be calculated by (number of counts outside 15 Gy isodose line / total number of counts within the liver) * global liver function.

    Secondary Outcome Measures

    Measure:Rate that theragnostically planned radiation is chosen for the radiation treatment plan
    Time Frame:Day -1 of Radiation Treatment
    Safety Issue:
    Description:The rate at which the plan that utilized the HIDA scan is chosen for the actual treatment will be summarized along with the corresponding exact 95% Binomial confidence interval.
    Measure:Local Control
    Time Frame:12 months
    Safety Issue:
    Description:Local control will be evaluated using RECIST 1.1 criteria.
    Measure:Progression Free Survival
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:Overall Survival
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:Time to transplant
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:Distant liver failure
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:Time until Salvage treatment
    Time Frame:12 months
    Safety Issue:
    Description:
    Measure:Treatment toxicity
    Time Frame:12 months
    Safety Issue:
    Description:The rate of decline of CTP class as well as the rate of any grade of hepatic toxicities will be collected and graded based on CTCAE
    Measure:Liver volume changes in treated and untreated liver
    Time Frame:12 months
    Safety Issue:
    Description:

    Details

    Phase:N/A
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Indiana University

    Trial Keywords

    • Radiation Treatment

    Last Updated